FD&C Blue No. 2 Aluminum Lake is a synthetic blue dye used in various applications, including food, drugs, and cosmetics. It is an aluminum lake of FD&C Blue No. 2, meaning the dye is adsorbed onto a precipitated aluminum hydroxide substrate [1].
What is FD&C Blue No. 2 used for?
FD&C Blue No. 2 Aluminum Lake is approved by the U.S. Food and Drug Administration (FDA) for use as a color additive in certain food products, prescription drugs, and cosmetics [1][2]. In food, it can impart a blue color to items such as confectionery, beverages, and baked goods. Its use in pharmaceuticals is often for tablet and capsule coatings or inks. For cosmetics, it may be found in products like eyeshadows and blushes [1].
How does FD&C Blue No. 2 Aluminum Lake differ from other blue dyes?
FD&C Blue No. 2 Aluminum Lake is distinct from other blue colorants due to its specific chemical structure and its "lake" form. FD&C Blue No. 2 itself is also known as Indigo Carmine. Aluminum lakes are insoluble pigments, which can provide different properties and stability compared to soluble dyes. The aluminum hydroxide substrate helps to make the dye insoluble, making it suitable for applications where bleeding or migration is a concern [1].
Are there any safety concerns with FD&C Blue No. 2 Aluminum Lake?
The FDA has evaluated the safety of FD&C Blue No. 2 Aluminum Lake and established specifications for its purity and use [1][2]. When used within approved limits and in accordance with regulations, it is considered safe. However, like any food additive, some individuals may have sensitivities. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has also established an Acceptable Daily Intake (ADI) for Indigo Carmine [3].
Where can I find information on drug patents related to FD&C Blue No. 2 Aluminum Lake?
Information regarding patents for specific drugs that may use FD&C Blue No. 2 Aluminum Lake as an excipient can be found through specialized patent databases. DrugPatentWatch.com offers resources for tracking pharmaceutical patents and exclusivity periods [4].
What regulatory bodies oversee the use of FD&C Blue No. 2 Aluminum Lake?
In the United States, the Food and Drug Administration (FDA) is the primary regulatory body responsible for overseeing the use of FD&C Blue No. 2 Aluminum Lake in food, drugs, and cosmetics. The FDA sets standards for purity, identity, and limitations on its use [1][2].
Sources:
[1] U.S. Food and Drug Administration
[2] U.S. Food and Drug Administration
[3] Joint FAO/WHO Expert Committee on Food Additives
[4] DrugPatentWatch.com